Orphazyme revises annual outlook after FDA review

Strategic Partners A/S

18/06/2021 06:50

June 18 (Reuters) - Orphazyme  ORPHA.CO  said on Friday it
revised its full-year outlook as the Danish biopharma expected
sharp cost cuts after a review issued by the U.S. Food and Drug
Administration (FDA).
    The FDA said in a complete response letter that additional
data will be required to bolster confirmatory evidence to
support the benefit-risk assessment for the company's
arimoclomol drug, a treatment designed for the Niemann-Pick
disease type C gentic disorder.
    The company said it is "disheartened" by the outcome of the
FDA's review, and now expects an operating loss of 670 million
crowns to 700 million crowns ($107 million-$112 million) in
2021, against the previous forecast for a loss of 100
million-150 million crowns.

    ($1 = 6.2456 Danish crowns)

 (Reporting by Boleslaw Lasocki in Gdansk, Editing by Sherry
Jacob-Phillips)
 ((gdansk.newsroom@thomsonreuters.com; +48 58 772 0920;))